The Healthcare Technology Solutions (HTS) operating division of Crothall Healthcare has received ISO 13485: 2016 recertification, an internationally recognized standard that includes servicing of medical devices. The certification process, overseen by NSF International Registrar, is conducted once every three years. Crothall’s HTS division received its initial certification in 2019.

“Our ISO 13485 recertification provides a tremendous benefit to our hospital and health system partners who can be reassured we have the policies, practices, and procedures to deliver consistent quality in repair and support services,” says Jim Cheek, president of Crothall Healthcare HTS. “This recertification reinforces the common quality language we speak that focuses on reducing variability in processes, utilizing client feedback to drive enhancements, and working with best-in-class suppliers. The result is enhanced patient safety and reduced medical device risk.”

The ISO 13485: 2016 standard sets the requirements for a Quality Management System with a focus on medical device safety. Certification is a recognition that Crothall’s policies, processes, and procedures ensure consistent quality in the repair and support services provided to clients. The certification audit covers everything from the uptime of medical devices and turnaround time on critical corrective maintenance work orders to ensuring the availability of equipment, device traceability, and supplier qualifications. 

Moreover, the certification and recertification process includes a comprehensive audit that reviews medical device safety, risk management, and process improvement. 

“Crothall’s HTS division oversees the entire life cycle of medical devices and clinical technologies at more than 200 hospitals nationwide,” adds Cheek. “Our clients and suppliers reap the benefits of the comprehensive continuous quality improvement program reflected by ISO’s rigorous certification standards and processes.”